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Custom Telfa Pack 82-01

by American Surgical Company, LLC

Custom Telfa Pack 82-01 is a neurosurgical sponge (FDA Class II; FDA product code HBA, Neurosurgical Paddie) made by American Surgical Company, LLC, cleared under FDA 510(k) K904514 on 27 Mar 1991 and listed in FDA GUDID since 3 Jan 2019 (UDI-DI 00749915002555), active as of 23 Oct 2026. 7 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 closed

Documents

510(k) K904514

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00749915002555 UDI-DI Date3 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK904514 Date27 Mar 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K904514 decided 27 Mar 1991 Active
  • FDA GUDID UDI-DI 00749915002555 listed 3 Jan 2019 Listed

Recalls

7 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-1805-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1800-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1802-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1804-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1806-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1803-2016 FDA Class II initiated 31 Mar 2016
    • Terminated Z-1801-2016 FDA Class II initiated 31 Mar 2016

    Product packaging defective compromising sterility

Timeline

9 dated events

  1. Cleared FDA 510(k) K904514
  2. Recall initiated FDA recalls Z-1805-2016
  3. Recall initiated FDA recalls Z-1800-2016
  4. Recall initiated FDA recalls Z-1802-2016
  5. Recall initiated FDA recalls Z-1804-2016
  6. Recall initiated FDA recalls Z-1806-2016
  7. Recall initiated FDA recalls Z-1803-2016
  8. Recall initiated FDA recalls Z-1801-2016
  9. Listed FDA GUDID 00749915002555

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Custom Telfa Pack
Generic name
Neurosurgical sponge
Model / reference
82-01
Primary DI / UDI-DI
00749915002555
510(k) Number
FDA product code
HBA
GMDN term
Neurosurgical sponge
Device class
Class II
Regulation number
882.4700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Neurosurgical sponge

Cleared under the same submission (K904514)

and 8 more cleared under K904514

Similar devices

Other devices filed under FDA product code HBA (Neurosurgical Paddie).

Other devices from American Surgical Company, LLC

  • ArmourSorb 88-04

    Class II

  • Uniqcot 67-06

    Class II

  • Uniqcot 67-86

    Class II

  • Tapered Delicot 63-09T

    Class II

See all devices from American Surgical Company, LLC →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)